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Last Updated: November 29, 2021

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Deferasirox - Generic Drug Details

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What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal, Aucta, MSN, Novartis, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Ichnos, Sun Pharm, Zydus Pharms, Annora Pharma, Celltrion, Cipla, Piramal Hlthcare Uk, Teva Pharms Usa, and Novartis Pharms Corp, and is included in twenty-seven NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has sixty-five patent family members in forty countries.

There are twenty drug master file entries for deferasirox. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for deferasirox

See drug prices for deferasirox

Recent Clinical Trials for deferasirox

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
DisperSol Technologies, LLCPhase 2
Fondazione Italiana Sindromi Mielodisplastiche-ETSPhase 2
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2

See all deferasirox clinical trials

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free500MGTABLET, FOR SUSPENSION;ORAL
⤷  Try it Free⤷  Try it Free250MGTABLET, FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for deferasirox
Paragraph IV (Patent) Challenges for DEFERASIROX
Tradename Dosage Ingredient NDA Submissiondate
JADENU TABLET;ORAL deferasirox 206910 2016-04-21
JADENU TABLET;ORAL deferasirox 206910 2015-10-19
EXJADE TABLET, FOR SUSPENSION;ORAL deferasirox 021882 2011-10-28

US Patents and Regulatory Information for deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm DEFERASIROX deferasirox TABLET;ORAL 211641-002 Jan 2, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Annora Pharma DEFERASIROX deferasirox TABLET;ORAL 214341-002 May 14, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal DEFERASIROX deferasirox TABLET;ORAL 210727-001 Dec 27, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Annora Pharma DEFERASIROX deferasirox TABLET;ORAL 214341-003 May 14, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Annora Pharma DEFERASIROX deferasirox TABLET;ORAL 214341-001 May 14, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 ⤷  Try it Free ⤷  Try it Free
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 ⤷  Try it Free ⤷  Try it Free
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 ⤷  Try it Free ⤷  Try it Free
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for deferasirox

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 PA2007001 Lithuania ⤷  Try it Free PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828
0914118 C00914118/01 Switzerland ⤷  Try it Free PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118 PA2007001,C0914118 Lithuania ⤷  Try it Free PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
0914118 SPC/GB07/002 United Kingdom ⤷  Try it Free SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
0914118 06C0049 France ⤷  Try it Free PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Baxter
Dow
Mallinckrodt
Merck

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